Devices and methods for continuous surgical suturing

ABSTRACT

A machine constructed and configured for automatic continuous suturing for reduced or minimized scarring and reduced suturing time, including methods of using the same. A device for continuous suturing. A device, method and suture for subcuticular suturing.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part of U.S. patent applicationSer. No. 13/898,103, filed May 20, 2013, now U.S. Pat. No. 9,220,498,which is a divisional of U.S. patent application Ser. No. 13/012,965,filed Jan. 25, 2011, now U.S. Pat. No. 8,465,504.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to surgical suturing methods and devices,and particularly to devices, machines, methods, needles, and stitchdesigns for cosmetic-grade suturing for reduced or minimized scarringand/or for organ or tissue internal suturing.

2. Description of the Prior Art

It is generally known in the prior art to provide specialized needlesand devices for suturing and for use with suture materials. Prior artpatent documents include the following:

U.S. Pat. No. 67,545 issued Aug. 6, 1867 for a spiral fissure needle;U.S. Pat. No. 196,226 issued Oct. 16, 1877 for a corkscrew; U.S. Pat.No. 242,602 issued Jun. 7, 1881 for a corkscrew; U.S. Pat. No. 349,791issued Sep. 28, 1886 for a suture instrument; U.S. Pat. No. 919,138issued Apr. 20, 1909 for a surgical needle; U.S. Pat. No. 1,583,271issued May 4, 1926 for a surgical instrument; U.S. Pat. No. 2,327,353issued Aug. 24, 1943 for an instrument for suturing; U.S. Pat. No.2,959,172 issued Nov. 8, 1960 for a self-threading suture instrument;U.S. Pat. No. 3,037,619 issued Jun. 5, 1962 for suture devices.

Also, it is known in the prior art to include a tubular needleconfiguration, such as in U.S. Pat. No. 4,204,541 issued May 27,1980 fora surgical instrument for stitching up soft tissues with lengths ofspiked suture material describes a surgical instrument for stitching upsoft tissues with lengths of spiked suture material that include ahollow body which houses a tubular needle having a through bore adaptedto accommodate said length of suture material to be introduced into thetissue being sutured along with the needle, and a stop stationary withrespect to the body and accommodated inside the through bore of theneedle. Both the needle and the stop are shaped as coils having the samediameter and lead, and the needle is mounted slidably along the stop soas to retain the length of suture material in the tissue being suturedwhile extracting the needle therefrom.

It is also provided in the prior art to provide suturing instruments,such as the following:

U.S. Pat. No. 4,440,171 issued Apr. 3, 1984 for a suturing instrumentand a method of holding a shuttle describes a surgical suturinginstrument that crosses and knots a suturing thread combining a shuttleand the other suturing thread passing through an eye of a curved needlein a lock stitching practice, for accomplishing smooth passage ofpassing the shuttle through a loop of the needle thread and exactcombination of the shuttle thread and the needle thread without gettingout the shuttle from a shuttle holder during the suturing operation soas to form sound suturing stitchings every time. The shuttle isaccommodated between a shuttle holder and a shuttle claw. The shuttle isformed with a front end portion movable between a guide groove in theshuttle claw and a guide groove in the shuttle holder. The shuttle isfurther formed with a sharp end for catching a thread loop in thesuturing operation.

U.S. Pat. No. 4,465,070 issued Aug. 14, 1984 for a stitching formationby a suturing instrument describes a suturing instrument used to formstitchings including stitching formation made by causing a shuttlethread to move in reciprocation on cut edges of a human part, betweenknottings and next knottings in a lock stitching, via an outer side of aneedle thread at a needle-out-hole from a needle-in-hole of a needle,thereby to make conglutination of the cut part stable and sound.

U.S. Pat. No. 4,524,771 issued Jun. 25, 1985 for a multiple curvedsurgical needle describes a needle which includes a plurality of curveswhich provide for improved control while suturing.

U.S. Pat. No. 4,641,652 issued Feb. 10, 1987 for a applicator for tyingsewing threads describes an applicator for utilization in combinationwith an endoscope tube includes a coil connected to a longitudinalpassage through a shaft and comprising hollow turns connected to theshaft passage for reception of a sewing thread, whose proximal extremityis passed through a loop projecting from a radial opening at the distalextremity of the shaft, is then drawn through the shaft passage andfastened to the proximal shaft extremity. Tying the single stitch afterpiercing the tissues is performed by passing the needle axially throughthe coil and then around the thread and twisting the coil out of theloop formed thereby to form the first half of a knot which is thencomplemented by the second half of the knot tied in the same way, theknot being tied by subsequently pulling together the two said halves.

U.S. Pat. No. 4,969,892 issued Nov. 13, 1990 for a suturing anchoringdevice for use in a female suspension procedure describes an anchoringmeans for anchoring a suture in tissue includes a housing, asubstantially cylindrical means within said housing for receiving asuture, and an adjusting means. Another anchoring means includes ahousing, a rotating spool within said housing, a driving gear, and anadjusting means.

U.S. Pat. No. 5,152,769 issued Oct. 6, 1992 for an apparatus forlaparoscopic suturing with improved suture needle describes a novelsuturing assembly defined by a new and improved suturing needle, havinga bore therethrough for forming an arc of thread to be grasped. Theassembly would comprise a first and second barrel portion, the portionsworking to allow a rod member to secure the arc of thread formed, andhold it in place, while the needle forms a second suture, and securesthe loop as part of the suture.

U.S. Pat. No. 5,356,424 issued Oct. 18, 1994 for a laparoscopic suturingdevice describes a laparoscopic suturing device that includes a suturingneedle and a driver for manipulating the needle.

U.S. Pat. No. 5,499,991 issued Mar. 19, 1996 for an endoscopic needlewith suture retriever describes a suture retriever and method formanipulating suture during endoscopic surgical procedures.

U.S. Pat. No. 5,507,743 issued Apr. 16, 1996 for a coiled RF electrodetreatment apparatus describes an RF treatment apparatus providesmulti-modality treatment for tumors and other desired tissue masses, andincludes an RF indifferent electrode and an active electrode.

U.S. Pat. No. 5,520,703 issued May 28, 1996 for a laparoscopic deschampand associated suturing technique describes a laparoscopic suturingdevice with an elongate shaft having a distal end and a proximal end andan arcuate tissue piercing element permanently fixed to the shaft at thedistal end, the arcuate tissue piercing element lying in a planedisposed substantially transversely to the shaft. The tissue piercingelement is provided at a free end, spaced from the shaft, with aneyelet, and the device has a suture thread extending through the eyelet.

U.S. Pat. No. 5,562,685 issued Oct. 8, 1996 for a surgical instrumentfor placing suture or fasteners and U.S. Pat. No. 5,709,692 issued Jan.20, 1998 for a surgical instrument for placing suture or fasteners at aremote location such as a laparoscopic surgery. The instrument is anelongated handle having a coiled projection at its distal end. Thecoiled projection is employed in penetrating and positioning a length ofsuture or fastener in tissue, for example, as in tissue proximation.

U.S. Pat. No. 5,810,851 issued Sep. 22, 1998 for a suture spring devicedescribes a guide used to position a suture spring device in anatomicaltissue in an elastically deformed, expanded state and is subsequentlyremoved to permit the suture spring device to move from the elasticallydeformed, expanded state toward a relaxed, contracted state to apply apredetermined compression to the tissue engaged by the device.

U.S. Pat. No. 5,911,689 issued Jun. 15, 1999 for a subcutaneousradiation reflection probe describes a subcutaneous radiation reflectionprobe for measuring oxygen saturation in living tissue includes anelongate drive shaft on one end of which is detachably coupled amounting cup.

U.S. Pat. No. 5,935,138 issued Aug. 10, 1999 for a spiral needle forendoscopic surgery describes a needle for endoscopic surgery is curvedinto an arc of more than 180.degree. And twisted, so that it forms apart of a spiral, with a lateral offset between the needle point andbarrel.

U.S. Pat. No. 5,947,983 issued Sep. 7, 1999 for a tissue cutting andstitching device and method describes a device for cutting tissue, thedevice comprising a first tube having a side window; a second tubepositioned within the first tube, the second tube having a side windowand being movable within the first tube; a third tube positioned withinthe second tube, the third tube having a side window and being movablewithin the second tube; and a needle insertable within the second tube,the needle housing a suture.

U.S. Pat. No. 6,113,610 issued Sep. 5, 2000 for a device and method forsuturing wound describes a needle assembly in which the needle isconstructed of a spring-like material and initially housed within asheath in a deformed condition. The needle can be easily exposed bysliding an actuator so as to release the constraining means and allowthe needle to assume its undeformed condition.

U.S. Pat. No. 6,520,973 issued Feb. 18, 2003 for an anastomosis devicehaving an improved needle driver describes an anastomosis device forattaching a first hollow vessel to a second hollow vessel. The deviceincludes a handle for holding the device, and a head assembly, attachedto the handle, for holding the first and second hollow vessels adjacentto each other. The head assembly having a distal end, a proximal end anda longitudinal axis there between. The device further includes a needleguide disposed longitudinally along the head assembly adjacent to thevessels, and a helical needle, having a suture attached to a proximalend thereof, disposed within the head assembly at its proximal end. Thedevice has an actuator on the handle for actuating a needle driver. Theneedle driver is coupled to the head and includes a flexible rotatablemember operated by the actuator, for rotating and driving the needledistally along the needle guides and through the first and second hollowvessels.

U.S. Pat. No. 6,537,248 issued Mar. 25, 2003 for a helical needleapparatus for creating a virtual electrode used for the ablation oftissue describes a surgical apparatus for delivering a conductive fluidto a target site for subsequent formation of a virtual electrode toablate bodily tissue at the target site by applying a current to thedelivered conductive fluid. The surgical apparatus includes an elongateddevice forming a helical needle.

U.S. Pat. No. 6,562,052 issued May 13, 2003 for a suturing device andmethod that allows a physician to remotely suture biological tissue.

U.S. Pat. No. 6,613,058 issued Sep. 2, 2003 for an anastomosis devicehaving needle receiver for capturing the needle after it has passedthrough the needle guide.

U.S. Pat. No. 6,626,917 issued Sep. 30, 2003 for a helical sutureinstrument which either pushes or pulls a suture along a helical needletract.

U.S. Pat. No. 6,663,633 issued Dec. 16, 2003 for a helical orthopedicfixation and reduction device, insertion system, and associated methodsdescribes a system for fixation of a soft tissue tear includes aflexible, generally helical fixation element biased to a predeterminedpitch and a hollow, generally helical insertion element dimensioned toadmit at least a distal portion of the fixation element into a lumenthereof.

U.S. Pat. No. 6,723,107 issued Apr. 20, 2004 for a method and apparatusfor suturing describes devices and techniques for suturing that areparticularly useful in laparoscopic, arthroscopic, and/or open surgicalprocedures. A method of delivering a suture includes providing a suturedevice, releasably coupling a suture to a distal end of a suture deviceby threading the suture through a first region of a bounded opening ofthe suture device and moving the suture to a second region of thebounded opening having a dimension smaller than a diameter of the sutureto trap the suture in the second region, penetrating a substrate withthe distal end of the suture device such that the a portion of thesuture passes through the substrate, and releasing the suture from thedistal end of the suture device.

U.S. Pat. No. 6,911,003 issued Jun. 28, 2005 for transobturator surgicalarticles and methods describe surgical articles, implants and componentssuitable for a transobturator surgical procedure.

U.S. Pat. No. 6,911,019 issued Jun. 28, 2005 for a helical needleapparatus for creating a virtual electrode used for the ablation oftissue describes a surgical apparatus for delivering a conductive fluidto a target site for subsequent formation of a virtual electrode toablate bodily tissue at the target site by applying a current to thedelivered conductive fluid.

U.S. Pat. No. 6,911,037 issued Jun. 28, 2005 for a retrievable septaldefect closure device describes a septal defect closure device having afirst occluding disk having a first flexible membrane attached to afirst frame and a second occluding disk having a second flexiblemembrane attached to a separate second frame. The first frame has atleast two outwardly extending loops joined to one another by flexiblejoints. These loops are attached to the first membrane to define tautfabric petals when the first disk is in a deployed configuration.

U.S. Pat. No. 6,923,807 issued Aug. 2, 2005 for a helical device andmethod for aiding the ablation and assessment of tissue describes ahelical needle attached to a surgical probe to aid in the insertion ofthe probe into a tissue mass.

U.S. Pat. No. 6,986,776 issued Jan. 17, 2006 for a suturing apparatus,method and system describes an apparatus used with a helical suturedevice has a first end and a second end. The first end includes aspatulate member having a length along a first axis. The second endincludes a guide shaped to receive a cylindrical axle of the helicalsuture device for rotation on a second axis. The guide is shaped toconstrain the first axis in fixed position relative to the second axis,the first and second axes each lying within a plane. The spatulatemember extends, typically symmetrically, in a first direction and asecond direction from the first axis, the first direction and seconddirection being on opposite sides of the plane. The apparatus liesbetween a first tissue that is to be sutured, and a second tissue thatis desired not to be sutured.

U.S. Pat. No. 7,070,556 issued Jul. 4, 2006 for transobturator surgicalarticles and methods describe a surgical instrument and method fortreating female urinary stress incontinence. The instrument includes afirst curved needle-like element defining in part a curved shaft havinga distal end and a proximal, a mesh for implanting into the lowerabdomen of a female to provide support to the urethra; a second curvedneedle element having a proximal end and a distal end, and a coupler forsimultaneous attachment to the distal end of the first needle and thedistal end of the second needle.

U.S. Pat. No. D543,626 issued May 29, 2007 for a handle for a surgicalinstrument describes an ornamental design for a handle for a surgicalinstrument

U.S. Pat. No. 7,235,087 issued Jun. 26, 2007 for an articulatingsuturing device and method describes devices, systems, and methods forsuturing of body lumens allow the suturing of vascular puncture siteslocated at the distal end of a percutaneous tissue tract.

U.S. Pat. No. 7,269,324 issued Sep. 11, 2007 for a helical fiber opticmode scrambler describes methods and apparatus of the present inventionprovide advantages for remote laser delivery systems that conduct highlevels of light energy through a fiber optic cable to a selectabletarget surface.

U.S. Pat. No. 7,288,105 issued Oct. 30, 2007 for a tissue openingoccluder describes a tissue opening occluder including first and secondoccluder portions, each occluder portion including a frame structure andan attachment structure to attach one portion to the other portion. Theframes may be utilized to constrain the tissue between the two portionsenough to restrict the significant passage of blood therethrough.

U.S. Pat. No. 7,290,494 issued Nov. 6, 2007 for a method formanufacturing stent-grafts describes a sewing machine which is capableof sewing reinforcing wire to tubular grafts in order to form stentgrafts. A bobbin (which may be seated in a shuttle) carries a bottomthread through the bore of the tubular graft and forms a stitch incombination with a top thread carried on a needle which pierces thegraft wall.

U.S. Pat. No. 7,309,325 issued Dec. 18, 2007 for a helical needleapparatus for creating a virtual electrode used for the ablation oftissue describes a surgical apparatus for delivering a conductive fluidto a target site for subsequent formation of a virtual electrode toablate bodily tissue at the target site by applying a current to thedelivered conductive fluid.

U.S. Pat. No. 7,323,004 issued Jan. 29, 2008 for a device for providingautomatic stitching of an incision describes an automatic suturingdevice including: a body for insertion into an opening in tissue; aplurality of hooks movably disposed in the body between retracted andextended positions; a suture holder having sutures disposed therein, thesuture holder having a mechanism for engaging a portion of the hookswhen in the retracted position and for attaching the sutures to aportion of the plurality of hooks; and an actuator for actuating theplurality of hooks from the retracted position to the extended positionand for embedding the exposed plurality of hooks with the attachedsutures into the tissue surrounding the opening.

U.S. Pat. No. 7,335,221 issued Feb. 26, 2008 for a suture anchoring andtensioning device and method for using same describes a suture anchoringdevice made from a coiled member having a helical configuration with amultiplicity of turns. When used in connection with a surgicalprocedure, the device is positioned adjacent to a wound site and asuture is attached to at least two of the turns so as to anchor thesuture to the coiled member.

U.S. Pat. No. 7,347,812 issued Mar. 25, 2008 for prolapse repairinstruments.

U.S. Pat. No. 7,351,197 issued Apr. 1, 2008 for a method and apparatusfor cystocele repair describes comprising the steps of: establishingfour pathways in tissue around a bladder of a patient, introducing astrap into each of said pathways, and positioning beneath said bladderof said patient a support member having each said strap connectedthereto such that said bladder of said patient is supported by saidsupport member and a bulge of said bladder into a vagina of said patientis reduced.

U.S. Pat. No. 7,357,773 issued Apr. 15, 2008 for a handle and surgicalarticle describes handles for needles suitable for pelvic floor surgicalprocedures.

U.S. Pat. No. 7,371,244 issued May 13, 2008 for a deployment apparatusfor suture anchoring device describes a deployment device for anchoringa suture to a suture anchoring device, which is made from a helicallycoiled member, includes a winding tube for winding a suture around thecoiled member in a helical path such that the suture is attached to atleast one turn of the coiled member.

U.S. Pat. No. 7,377,936 issued May 27, 2008 for a retrievable septaldefect closure device describes a septal defect closure device having afirst occluding disk having a first flexible membrane attached to afirst frame and a second occluding disk having a second flexiblemembrane attached to a separate second frame. The first frame has atleast two outwardly extending loops joined to one another by flexiblejoints. These loops are attached to the first membrane to define tautfabric petals when the first disk is in a deployed configuration.

U.S. Pat. No. 7,479,155 issued Jan. 20, 2009 for a defect occluderrelease assembly and method describes a release assembly is provided toaid the reversible and repositionable deployment of a defect occluder.The release assembly includes an occluder tether having a distal portioncomprising at least one suture loop, and a snare structure having adistal portion comprising a snare element. The at least one suture loopis receivable through at least a portion of the defect occluder, andreversibly looped over an anchor element so as to permit reversiblecollapse the defect occluder for selective ingress and egress from adelivery catheter. The snare element is reversibly engageable with theanchor element so as to reversibly retain the at least one suture loopupon the anchor element, and thereby hold the defect occluder in aposture for reversible free-floating tethered deployment in a defectwhile being observable in a final position prior to release.

U.S. Pat. No. 7,500,945 issued Mar. 10, 2009 for a method and apparatusfor treating pelvic organ prolapse describes the steps of establishing afirst pathway between the external perirectal region of the patient tothe region of the ischial spine in tissue on one side of the prolapsedorgan, followed by establishing a second pathway in tissue on thecontralateral side of the prolapsed organ. A support member, whichincludes a central support portion and two end portions, is positionedin a position to reposition said prolapsed organ in said organ'sanatomically correct location. The end portions of the support memberare introduced through the respective tissue pathways, followed byadjustment of the end portions so that the support member is located ina therapeutic relationship to the prolapsed organ that is to besupported.

U.S. Pat. No. 7,582,103 issued Sep. 1, 2009 for a tissue openingoccluder describes a tissue opening occluder comprising first and secondoccluder portions, each occluder portion including a frame structure andan attachment structure to attach one portion to the other portion. Theframes may be utilized to constrain the tissue between the two portionsenough to restrict the significant passage of blood therethrough.

U.S. Pat. No. 7,588,583 issued Sep. 15, 2009 for a suturing device,system and method describes improved medical suturing devices, systems,and methods to hold a suture needle at a fixed location relative to ahandle of the device, allowing the surgeon to grasp and manipulate thehandle of the suturing device to insert the needle through tissues in amanner analogous to use of a standard needle gripper.

U.S. Pat. No. 7,637,918 issued Dec. 29, 2009 for a helical suturingdevice describes an apparatus for repairing a tear in an annulusfibrosus of a spinal disc includes a hollow, helically-shaped suturingneedle and a retriever.

U.S. Pat. No. 7,686,821 issued Mar. 30, 2010 for an apparatus and methodfor positive closure of an internal tissue membrane opening describes adevice having two components: a needle advancing apparatus slidablelongitudinally along a catheter to advance needles into a tissuemembrane, such as a blood vessel wall, around an opening in themembrane; and, a suture retrieval assembly insertable through thecatheter beyond a distal side of the tissue membrane.

U.S. Pat. No. 7,699,805 issued Apr. 20, 2010 for a helical coilapparatus for ablation of tissue describes a surgical apparatus fordelivering a conductive fluid to a target site for subsequent formationof a virtual electrode to ablate bodily tissue at the target site byapplying a current to the delivered conductive fluid.

U.S. Pat. No. 7,699,857 issued Apr. 20, 2010 for a hydrodynamic suturepasser describes a hydrodynamic suturing instrument, comprises anelongated cannulated suturing needle having a distal end configured tocarry a suture through tissue and a proximal end adapted to connect to asyringe barrel and a lumen extending from said proximal end to anopening at the distal end for having a size for the passage of a suture,and the opening at the distal end configured to receive a sutureextending from the lumen along an outer surface of the needle wherein asharp point extends forward of the suture. A companion instrumentincludes forceps having a distal end with jaws and a proximal end with alumen extending from the proximal end to the distal end for passage ofthe needle, and the jaws having an opening enabling passage of theneedle through tissue grasped in the jaws.

U.S. Pat. No. 7,699,892 issued Apr. 20, 2010 for a minimally invasiveprocedure for implanting an annuloplasty device describes a method formodifying a heart valve annulus includes placing a purse string sutureat a puncture site adjacent a heart valve, inserting at least onedelivery member through the puncture site, positioning a distal end ofthe at least one delivery member adjacent a portion of a valve annulus,deploying an annuloplasty device carried within the at least onedelivery member and implanting the annuloplasty device into the valveannulus. The method also includes reshaping the heart valve annulusafter implantation of the at least one annuloplasty device.

U.S. Pat. No. 7,776,059 issued Aug. 17, 2010 for a suturing methoddescribes an apparatus used with a helical suture device has a first endand a second end. The first end includes a spatulate member having alength along a first axis. The second end includes a guide shaped toreceive a cylindrical axle of the helical suture device for rotation ona second axis. The guide is shaped to constrain the first axis in fixedposition relative to the second axis, the first and second axes eachlying within a plane. The spatulate member extends, typicallysymmetrically, in a first direction and a second direction from thefirst axis, the first direction and second direction being on oppositesides of the plane. The apparatus lies between a first tissue that is tobe sutured, and a second tissue that is desired not to be sutured.

U.S. Pat. No. 7,780,700 issued Aug. 24, 2010 for a patent foramen ovaleclosure system describes a patent foramen ovale closure device, methodof delivering and a delivery system are provided. The device may includea closure device releasably connectable to an actuator. The device mayinclude a proximal segment, an intermediate segment and a distalsegment. When delivered, the proximal segment and intermediate segmentform a first clip-shaped portion sized and configured to be positionedover a septum secundum of the patent foramen ovale, and the intermediatesegment and distal segment form a second clip-shaped portion sized andconfigured to be positioned over a septum primum of the patent foramenovale.

U.S. Pat. No. 7,794,471 issued Sep. 14, 2010 for a compliant anastomosissystem describes an integrated anastomosis tool may include an effectorthat both makes an opening in the wall of a target vessel and connects agraft vessel to the target vessel. The connection between the graftvessel and the target vessel may be compliant, and may be achieved bydeploying a plurality of connectors such as staples into tissue.

SUMMARY OF THE INVENTION

The present invention relates to suturing methods and devices, includingmachines, needles, and methods of using them, and also for the stitchesproduced thereby, for suturing with reduced or minimized scarring, andthat is especially useful for cosmetic-grade suturing applications andreducing suturing time.

It is an object of this invention to provide a machine constructed andconfigured for automatic suturing for reduced or substantially minimizedscarring and reducing suturing time.

It is an object of this invention to provide methods for using a machineoperable for automatic suturing for reduced or substantially minimizedscarring and reducing suturing time.

Yet another object of this invention is to provide a suture needledesigned and constructed for suturing, and more particularly for usewith a machine operable for automatic suturing for reduced orsubstantially minimized scarring and reducing suturing time.

A further object of this invention is to provide a variety ofalternative embodiments for suture needles designed and constructed forsuturing, and more particularly for use with a device and/or a machineoperable for automatic suturing for reduced or substantially minimizedscarring and reducing suturing time.

Still another object of the present invention is to provide a continuousconnection of loops forming a suture stitch for suturing with reduced orsubstantially minimized scarring and reducing suturing time.

These and other aspects of the present invention will become apparent tothose skilled in the art after a reading of the following description ofthe preferred embodiment when considered with the drawings, as theysupport the claimed invention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view diagram of the main components of the headof a device for suturing showing skin subcuticular suturing embodimentof the invention.

FIG. 2 is a perspective view diagram illustrating the head of a devicefor suturing according to one embodiment of the invention.

FIG. 3 shows a perspective view diagram illustrating a portion of anautomated machine for suturing from FIG. 1 focused on the hook andsuture needle interaction for forming continuous suture stitchesaccording to one embodiment of the invention.

FIG. 3A is a perspective view diagram of the portion of the automatedmachine in a position of operation for completing a stitch automated bythe machine of the present invention.

FIG. 3B is a perspective view diagram of the portion of the automatedmachine in a position of operation for completing a stitch automated bythe machine of the present invention.

FIG. 3C is a perspective view diagram of the portion of the automatedmachine in a position of operation for completing a stitch automated bythe machine of the present invention.

FIG. 3D is a perspective view diagram of the portion of the automatedmachine in a position of operation for completing a stitch automated bythe machine of the present invention.

FIG. 3E is a perspective view diagram of the portion of the automatedmachine in a position of operation for completing a stitch automated bythe machine of the present invention.

FIG. 3F is a perspective view diagram of the portion of the automatedmachine in a position of operation for completing a stitch automated bythe machine of the present invention.

FIG. 3G is a perspective view diagram of the portion of the automatedmachine in a position of operation for completing a stitch automated bythe machine of the present invention.

FIG. 3H is a perspective view diagram of the portion of the automatedmachine in a position of operation for completing a stitch automated bythe machine of the present invention.

FIG. 3I is a perspective view diagram of the portion of the automatedmachine in a position of operation for completing a stitch automated bythe machine of the present invention.

FIG. 3J is a perspective view diagram of the portion of the automatedmachine in a position of operation for completing a stitch automated bythe machine of the present invention.

FIG. 4 shows the offset subcuticular skin suturing mechanism of FIG. 1.with the tip of the helico-spiral suture needle in the home position(outside the skin).

FIG. 5 shows the offset subcuticular skin suturing mechanism of FIG. 1.with the tip of the helico-spiral suture needle in its final positionafter completing one skin bite.

FIG. 6 shows a top view diagram illustrating a stitching pattern for asingle unit cycle for making continuous suturing made by an automatedmachine for suturing according to one embodiment of the invention.

FIG. 7A illustrates a perspective view for continuous suture stitchingforming chains of single unit cycles illustrated from FIG. 6.

FIG. 7B illustrates a perspective view for continuous suture stitchingforming chains of single unit cycles illustrated from FIG. 6.

FIG. 7C illustrates a perspective view for continuous suture stitchingforming chains of single unit cycles illustrated from FIG. 6.

FIG. 8A shows a perspective view illustrating a solid suture needle inalternative embodiments for use in suturing according to the presentinvention.

FIG. 8B shows a perspective view illustrating a solid suture needle inalternative embodiments for use in suturing according to the presentinvention.

FIG. 8C shows a perspective view illustrating a solid suture needle inalternative embodiments for use in suturing according to the presentinvention.

FIG. 9A shows a perspective view illustrating a hollow suture needle inalternative embodiments for use in suturing according to the presentinvention.

FIG. 9B shows a perspective view illustrating a hollow suture needle inalternative embodiments for use in suturing according to the presentinvention.

FIG. 9C shows a perspective view illustrating a hollow suture needle inalternative embodiments for use in suturing according to the presentinvention.

FIG. 10A shows a perspective view illustrating a hook in alternativeembodiments for use with an automated machine for suturing of thepresent invention.

FIG. 10B shows a perspective view illustrating a hook in alternativeembodiments for use with an automated machine for suturing of thepresent invention.

FIG. 10C shows a perspective view illustrating a hook in alternativeembodiments for use with an automated machine for suturing of thepresent invention.

FIG. 11 is a table of commercial suture materials and prior art sutureneedle references.

FIG. 12 is a table from Johnson & Johnson that shows commercial sutureneedle information references.

FIG. 13A is a perspective view diagram of the complete head portion ofthe automated machine in a position of operation for completing a stitchautomated by the machine of the present invention.

FIG. 13B is a perspective view diagram of the complete head portion ofthe automated machine in a position of operation for completing a stitchautomated by the machine of the present invention.

FIG. 13C is a perspective view diagram of the complete head portion ofthe automated machine in a position of operation for completing a stitchautomated by the machine of the present invention.

FIG. 13D is a perspective view diagram of the complete head portion ofthe automated machine in a position of operation for completing a stitchautomated by the machine of the present invention.

FIG. 13E is a perspective view diagram of the complete head portion ofthe automated machine in a position of operation for completing a stitchautomated by the machine of the present invention.

FIG. 13F is a perspective view diagram of the complete head portion ofthe automated machine in a position of operation for completing a stitchautomated by the machine of the present invention.

FIG. 13G is a perspective view diagram of the complete head portion ofthe automated machine in a position of operation for completing a stitchautomated by the machine of the present invention.

FIG. 13H is a perspective view diagram of the complete head portion ofthe automated machine in a position of operation for completing a stitchautomated by the machine of the present invention.

FIG. 13I is a perspective view diagram of the complete head portion ofthe automated machine in a position of operation for completing a stitchautomated by the machine of the present invention.

FIG. 13J is a perspective view diagram of the complete head portion ofthe automated machine in a position of operation for completing a stitchautomated by the machine of the present invention.

FIG. 13K is a perspective view diagram of the complete head portion ofthe automated machine in a position of operation for completing a stitchautomated by the machine of the present invention.

FIG. 14A shows a perspective view diagram of the inferior angle of thehead portion of the automated machine in a position of operation forcompleting a stitch in suturing automated by the machine of the presentinvention.

FIG. 14B shows a perspective view diagram of the inferior angle of thehead portion of the automated machine in a position of operation forcompleting a stitch in suturing automated by the machine of the presentinvention.

FIG. 14C shows a perspective view diagram of the inferior angle of thehead portion of the automated machine in a position of operation forcompleting a stitch in suturing automated by the machine of the presentinvention.

FIG. 14D shows a perspective view diagram of the inferior angle of thehead portion of the automated machine in a position of operation forcompleting a stitch in suturing automated by the machine of the presentinvention.

FIG. 14E shows a perspective view diagram of the inferior angle of thehead portion of the automated machine in a position of operation forcompleting a stitch in suturing automated by the machine of the presentinvention.

FIG. 14F shows a perspective view diagram of the inferior angle of thehead portion of the automated machine in a position of operation forcompleting a stitch in suturing automated by the machine of the presentinvention.

FIG. 14G shows a perspective view diagram of the inferior angle of thehead portion of the automated machine in a position of operation forcompleting a stitch in suturing automated by the machine of the presentinvention.

FIG. 14H shows a perspective view diagram of the inferior angle of thehead portion of the automated machine in a position of operation forcompleting a stitch in suturing automated by the machine of the presentinvention.

FIG. 14I shows a perspective view diagram of the inferior angle of thehead portion of the automated machine in a position of operation forcompleting a stitch in suturing automated by the machine of the presentinvention.

FIG. 14J shows a perspective view diagram of the inferior angle of thehead portion of the automated machine in a position of operation forcompleting a stitch in suturing automated by the machine of the presentinvention.

FIG. 14K shows a perspective view diagram of the inferior angle of thehead portion of the automated machine in a position of operation forcompleting a stitch in suturing automated by the machine of the presentinvention.

FIG. 15A shows a perspective view diagram of the complete head portionin a position of operation for completing a stitch in suturing by themachine of the present invention.

FIG. 15B shows a perspective view diagram of the complete head portionin a position of operation for completing a stitch in suturing by themachine of the present invention.

FIG. 15C shows a perspective view diagram of the complete head portionin a position of operation for completing a stitch in suturing by themachine of the present invention.

FIG. 15D shows a perspective view diagram of the complete head portionin a position of operation for completing a stitch in suturing by themachine of the present invention.

FIG. 15E shows a perspective view diagram of the complete head portionin a position of operation for completing a stitch in suturing by themachine of the present invention.

FIG. 15F shows a perspective view diagram of the complete head portionin a position of operation for completing a stitch in suturing by themachine of the present invention.

FIG. 15G shows a perspective view diagram of the complete head portionin a position of operation for completing a stitch in suturing by themachine of the present invention.

FIG. 15H shows a perspective view diagram of the complete head portionin a position of operation for completing a stitch in suturing by themachine of the present invention.

FIG. 15I shows a perspective view diagram of the complete head portionin a position of operation for completing a stitch in suturing by themachine of the present invention.

FIG. 15J shows a perspective view diagram of the complete head portionin a position of operation for completing a stitch in suturing by themachine of the present invention.

FIG. 15K shows a perspective view diagram of the complete head portionin a position of operation for completing a stitch in suturing by themachine of the present invention.

FIG. 15L shows a perspective view diagram of the complete head portionin a position of operation for completing a stitch in suturing by themachine of the present invention.

FIG. 15M shows a perspective view diagram of the complete head portionin a position of operation for completing a stitch in suturing by themachine of the present invention.

FIG. 15N shows a perspective view diagram of the complete head portionin a position of operation for completing a stitch in suturing by themachine of the present invention.

FIG. 15O shows a perspective view diagram of the complete head portionin a position of operation for completing a stitch in suturing by themachine of the present invention.

FIG. 15P shows a perspective view diagram of the complete head portionin a position of operation for completing a stitch in suturing by themachine of the present invention.

FIG. 15Q shows a perspective view diagram of the complete head portionin a position of operation for completing a stitch in suturing by themachine of the present invention.

FIG. 15R shows a perspective view diagram of the complete head portionin a position of operation for completing a stitch in suturing by themachine of the present invention.

FIG. 15S shows a perspective view diagram of the complete head portionin a position of operation for completing a stitch in suturing by themachine of the present invention.

FIG. 15T shows a perspective view diagram of the complete head portionin a position of operation for completing a stitch in suturing by themachine of the present invention.

FIG. 16A shows a preferred embodiment of the complete suturing moduleassembly encased within a general housing of the present invention.

FIG. 16B shows a preferred embodiment of the complete suturing moduleassembly encased within a general housing of the present invention.

FIG. 17A shows a complete handle and suturing module assembly of thepresent invention.

FIG. 17B shows a complete handle and suturing module assembly of thepresent invention.

FIG. 18A shows an alternative embodiment incorporating a suture threadsupply connected to a tensioner of the present invention.

FIG. 18B shows an alternative embodiment incorporating a suture threadsupply connected to a tensioner of the present invention.

FIG. 18C shows an alternative embodiment incorporating a suture threadsupply connected to a tensioner of the present invention.

FIG. 19 shows a suture tensioner according to the present invention.

FIG. 20A shows a compound needle with a hook and closing element.

FIG. 20B shows a compound needle with a hook and closing element.

FIG. 20C shows a compound needle with a hook and closing element.

FIG. 20D shows a compound needle with a hook and closing element.

FIG. 20E shows a compound needle with a hook and closing element.

FIG. 21A shows a suturing module assembly with a 90 degree footing.

FIG. 21B displays a suturing module assembly with a 45 degree angledfooting.

LIST OF INDICIA

-   -   10 machine    -   11 head portion    -   12 housing    -   14 suture needle plane    -   15 helical axis of suture needle    -   16 needle eyelet    -   17 needle shaft    -   18 suture needle (hollow or solid)    -   19 hook spring    -   20 hook    -   21 hook rod    -   22 retracted hook position.    -   23 extended hook position    -   24 hook shank    -   25 hook point    -   26 hook gape (gap)    -   27 hook bend    -   30 compound needle    -   31 push arm    -   33 holding arm head length    -   34 loop    -   35 holding arm spindle    -   36 holding arm or pusher    -   37 holding arm rotary shaft    -   38 holding arm rotary shaft wheel    -   39 holding arm shaft    -   40 thread supply    -   41 thread supply post    -   42 thread guide    -   43 suture, suture thread    -   44 catch arm    -   45 tensioner    -   46 bolt (tensioner)    -   47 spring (tensioner)    -   48 suture bobbin    -   49 holding arm head    -   50 edge separator    -   51 helix pitch    -   52 higher side of cut    -   53 lower side of cut    -   54 flat surface of footing    -   55 edge offset distance    -   60 complete suturing module assembly    -   62 complete handle    -   70 tongue    -   71 spring seat

DETAILED DESCRIPTION

The present invention provides a device constructed and configured forautomatic suturing for reduced or minimized scarring, reducing suturingtime and methods for using a machine operable for automatic suturing.Additionally, the present invention provides a variety of suture needles, designed and constructed for suturing to minimize or eliminatescarring, reducing suturing time and more particularly for use incombination with hooks for making a continuous suture stitch with amachine operable for automatic suturing for reduced or minimizedscarring, reducing suturing time.

As set forth herein, the present invention provides machines, methodsand suture needle designs for automatic suturing with minimum scarringand reducing suturing time. Referring now to the drawings in general,the illustrations are for the purpose of describing a preferredembodiment of the invention and are not intended to limit the inventionthereto.

FIG. 1 is a perspective view diagram of the main components of the headof a device for suturing showing skin subcuticular suturing embodimentof the invention.

FIG. 2 is a perspective view diagram illustrating the main components ofthe head of a device for suturing according to one embodiment of theinvention. FIG. 3 shows a perspective view diagram illustrating aportion of the main components of the head of a device for suturing fromFIG. 2 focused on the hook and suture needle interaction for formingcontinuous suture stitches according to one embodiment of the invention.The suture machine is generally referenced 10, and includes at least thefollowing components constructed and configured in operable connectionfor automatically producing a stitch: a support base or housing 12, asuture thread supply (not shown) having a first end and a second end,removably (movable) mounted on the support base via a connectingcylindrical post (not shown), a substantially spiral-shaped hollowsuture needle 18 movable rotationally between a first (home position)and second position for forming a stitch, and a hook 20 (FIG. 3) movablebetween a retracted 22 and an extended position (23, FIG. 3D, closertoward the suture needle tip than the retracted position, 22) by anautomated gear device (not shown). The machine for making suturestitches automatically according to the present invention preferablyincludes a machine body or base for supporting or otherwise connectableto a suture thread supply, a suture needle constructed and configuredfor receiving and manipulating a first end of the suture thread supply,wherein the suture needle is rotationally movable so that a sutureneedle tip advances between a first and second position for adjoining atleast two edges for continuously stitching them together in asubstantially edge-to-edge interface without overlapping the edges,aided by a wound separator mounted on or part of the machine body 12ahead of the suture line (the wound separator is not shown) therebyproviding an automated device for making suture stitches that produceminimal scarring on tissue, organs, or skin. The wound separator is toprevent wound overlapping.

In an automated machine for suturing according to an alternativeembodiment of the present invention from FIG. 2, note that the hookdevice mechanism may be constructed and configured to be in an angledposition; preferably, the hook device mechanism is adjustable, but inany position, the hook is always configured to be in parallel to thespiral suture needle. However, overall components and functionality aresubstantially similar to the foregoing description, but the angledpositioning of these components is preferred for forming a “sideways”suture using a helical suture needle. The angle of the spiral sutureneedle axis in relation to the surface of the tissue to be sutured ispreferably adjustable between about 10 degrees and about 90 degrees,wherein 90 degrees angle is perpendicular to the wound or tissue surfacewhere the suturing is made (i.e., the suturing zone), preferably betweenabout 25 and about 90 degrees, and more preferably between about 45 andabout 90 degrees. The application and type of suture are factorsaffecting the angle. The angles provide for creating hidden sutures andin the use of suturing fascia, muscles, or hollow organs, such as theintestines, wherein the skin adjoined by the sutures is substantially orperfectly flat, and without overlap, thereby minimizing scarring.

FIG. 2 is a perspective view diagram illustrating the head of a devicefor suturing according to one embodiment of the invention.

FIG. 3 shows a perspective view diagram illustrating a portion of anautomated machine for suturing from FIG. 2 focused on the hook andsuture needle interaction for forming continuous suture stitchesaccording to one embodiment of the invention.

FIG. 3 views A, B, C, D, E, F, G, H, I, and J illustrate a perspectiveview diagram of the portion of the automated machine of FIG. 3 shown invarious positions of operation for a single cycle completing a stitch insuturing automated by the machine of the present invention.

FIG. 3 shows a perspective view diagram illustrating a portion of anautomated machine for suturing according to one embodiment of theinvention. Furthermore, FIG. 3 views A, B, C, D, E, F, G, H, I, and Jillustrate a perspective view diagram of the portion of the automatedmachine of FIG. 3 shown in various positions of operation for a singlecycle completing a stitch in suturing automated by the machine of thepresent invention. By moving through this cycle automatically, a hook 20is moved by a rotating gear (not shown) between a first retractedposition (FIG. 3A) after catching a loop 34 made with the suture threadthat is picked up next by a holding arm comprising a push arm 31 and acatch arm 44. The push arm 31 and catch arm 44 coordinate movements asshown in positions B, C, D, and E to allow the hook to move into asecond extended position to release the loop and then move to catch thenext loop (if any, depending on the length of the chain of stitches)illustrated in F and G positions. In this method, the suture stitch isformed of a series of interconnected loops (single stitch unit cycle isillustrated in FIG. 6; continuous series illustrated in FIGS. 7A, 7B,7C) by the cooperation, coordination and synchronization of the sutureneedle and hook components to effectively knit the suture stitches intoa connected chain that is continuous and substantially planar.

Methods for making suture stitches automatically according to thepresent invention include the steps of: providing a machine having asuture thread supply, a suture needle constructed and configured forreceiving and manipulating a first end of the suture thread supply,rotationally moving the suture needle and thread to create a suturestitch by advancing the suture needle position, and adjoining at leasttwo edges for continuously stitching them together in a substantiallyedge-to-edge interface, thereby making suture stitches that produceminimal scarring on tissue, organs, or skin and reducing suturing time.

In preferred methods, the step of moving the suture needle rotationallyto create a suture stitch is automatically made, by activating themachine to move the suture needle to create a first rotational part ofthe stitch, introducing a hook in a retracted position to catch thestitch at the end of the rotational movement, reversing the direction ofrotation of the suture needle, moving the hook to a second extendedposition and releasing the stitch, and extracting the suture needle tocomplete the stitch. After the suture needle and hook form a singlestitch, or a series of connected stitches, depending upon the size ofthe suture area, preferably the suture thread will be cut, by scissors,or other sharp utensil. Additional cutting mechanism (not shown) can beadded to the body of the machine such as a vertical blade retracted in agroove in the body of the machine. Such blade has a distal sharp flatend and blunt proximal end. The distal end is close to the stitch loopwhen such loop is pulled up by the hook in a retracted position insidethe body of the machine. The proximal end is connected to a springloaded button that is operated manually by the surgeon. At the end ofthe suture line, the surgeon can go back and forth with continuoussuturing to ensure the security of the suture end. Then the surgeonpushes the button, which in return pushes the rod down to let the distalsharp flat end cut the suture material and to end the continuous line ofsuturing.

FIG. 6 shows a top view diagram illustrating a stitching pattern for asingle unit cycle for making continuous suturing made by an automatedmachine for suturing according to one embodiment of the invention.

FIGS. 7 A, B, and C illustrate in perspective views three alternativesfor continuous suture stitching forming chains of single unit cyclesillustrated from FIG. 6.

A suture stitch single unit cycle formed from the method describedhereinabove is illustrated in FIG. 6, and in FIGS. 7A, 7B, and 7C, it isshown in one continuous suture stitch chain embodiment formed from aseries of interconnected stitches by repeating the foregoing steps: FIG.7A shows 5 units repeated and in a spaced apart manner so that thecircular portion of the stitch unit cycle does not directly touch or isnot directly juxtaposed another stitch unit cycle; FIG. 7B shows 7 unitsrepeated that are directly touching, i.e., the circular portion of thestitch unit cycle is formed and positioned so that it is directly orapproximately directly juxtaposed the next stitch unit cycle; FIG. 7Cshows 5 stitch unit cycles wherein the circular portion of each unitcycle is overlapping with an adjacent stitch unit circular portion. Themethod of forming the stitch includes rotational movement of the sutureneedle via rotation of a shaft along its axis. Then parallel to thesuture needle shaft (shown in FIG. 3), a hook catches the loop formed bythe suture thread from the rotational suture needle movement (before orjust after the suture needle reverses direction) and the hook pulls theloop out of the plane, as illustrated in FIG. 3 and FIG. 3 views, forforming a chain or continuous connection of a series of loops formed bythe suture needle movement of the suture thread (single stitch unitcycle illustrated in FIG. 6; continuous suture stitching embodimentsillustrated in FIGS. 7A, 7B, and 7C).

FIG. 8 shows three perspective views 8A, 8B, and 8C each illustrating asolid suture needle in alternative embodiments for use in suturingaccording to the present invention.

FIG. 9 shows three perspective views 9A (spiral suture needle), 9B(helico-spiral suture needle), and 9C (helical suture needle) eachillustrating a hollow suture needle in alternative embodiments for usein suturing according to the present invention.

For a spiral suture needle as in FIG. 8A or FIG. 9A, or for thehelico-spiral suture needle FIG. 8B or 9B, the hook is positionedpreferably at 90 degree angle to the suture needle. For a helical sutureneedle, as illustrated in FIGS. 8C, 9C, the hook is preferablypositioned at an angle with respect to the suture needle. For using alatch hook as in FIG. 10A, the process is not entirely dissimilar fromknitting methods for creating a continuous chain of loops; however, analternative embodiment for the machine is required (completely differentfrom knitting machines and methods, requiring an additional catchermechanism) when using a non-latch hook as illustrated in FIGS. 10B and10C; in preferred embodiments, the shorter hook of FIG. 10B is used.

As illustrated in the figures, the present invention and machine andmethods of using same further include a spiral-shaped suture needle formaking suture stitches wherein the suture needle includes a continuouslyhollow suture needle body having a first end positioned a spaced apartdistance from a second pointed, sharp end, wherein the suture needlebody forms a spiral having at least two complete turns around a centerpoint, wherein the second end is positioned at the outermost spiral. Asshown FIG. 9 provides three perspective views 9A, 9B, and 9C eachillustrating a suture needle in alternative embodiments for use insuturing and for use with an automated machine for suturing of thepresent invention. The suture needle body is an elongated metal cylinderthat is formed and configured to be spiraled for forming the stitch forsuturing in an edge-to-edge manner without substantial overlapping ofthe tissue, skin or organ. The important dimensions for the sutureneedle are the diameter; the height is a secondary dimensionconsideration. For a hollow suture needle, the suture needle tube outerdiameter is preferably between about 1 mm and about 3 mm; morepreferably between about 1 mm to about 2 mm. The suture needle spiraldimension is between about 5 mm to about 25 mm; more preferably betweenabout 5 mm and about 15 mm. For the solid suture needle, the same outerdiameter and the suture needle spiral dimension apply. The dimensionsfor the suture needle depend upon the type and size of suture thread,type and nature of tissue being connected with the suture (e.g., facialskin would require a finer suture needle with smaller dimensions), andother factors, including whether it is an open wound or inside the body,the size and dimensions of the device or machine, and the like. Also,the length of the suture needle is dependent upon the number of coils inthe spiral, which is a function of the application, or the type ofsuture thread, type of tissue being connected with the suture, etc.

By way of example, typically used for the skin, 5/0 monocryl suture, thesuture needle will have outer diameter of 0.36 mm and curvature of 11mm. For fascia, muscles, and internal organs, such as intestines, largersize sutures from 4/0 up to about #2 would require much larger sutureneedle and curvature. Smaller sizes would be used for microsurgery, andeye surgery.

FIG. 11 from Ethicon shows commercial suture materials and prior artsuture needle references.

FIG. 12 from Johnson & Johnson shows commercial suture needleinformation references.

In one embodiment, preferably the second pointed sharp end is angled toform an ovular opening in the suture needle body. Such opening ispreferred to have smooth rounded edges to allow the suture material toslide easily with minimal friction especially if used with the hollowhelico-spiral suture needle. Preferably the suture needle furtherincludes an opening spaced apart from the second pointed sharp end ofthe suture needle for forming the suture stitch and to allow the suturethread to exit at the side or edge of the tissue.

A latch needle or spring needle or hybrid of both may be used withmachines of the present invention. Steps for methods of using theseknitting needles with or without the machines of the present inventioninclude: inserting the suture needle at the point or location for thefirst suture stitch; catching the suture stitch with the hook; pullingout the suture needle by reversing its rotation; the hook releasing theloop; holding the loop by the catcher, hooking the next loop by the hookand pulling it through the previous suture stitch loop (illustrated bythe positions of machine components in FIG. 3A-G) to form asubstantially parallel series of continuous loops along the suturetissue line. In a significant difference from knitting known in theprior art, the stitching of loops for forming the sutures of the presentinvention are formed in a single flat line and only connected on asingle side of the loop of the stitches, as illustrated in FIG. 6.

FIG. 6 illustrates a view showing single side loops that are connected.

The bottom loop goes through the opposing side loop for interconnectingand closing the wound from both sides. These illustrations in thefigures provide step by step methods for making the suture according tothe present invention, and also show the device and/or machine componentpositioning and configuration at each step. Depending upon where thenext stitch entry is made determines the pattern and closure for thesuture stitch; three embodiments of suture stitch chains areillustrated, from spaced apart non-interlacing or overlapping loops; toanother view showing adjacent loops that are juxtaposed but notoverlapping; and a third view showing overlapping or interlacing loopsor stitches. In each example embodiment, a perspective view is shown.

In preferred embodiments, it is better to stretch the stitch longer,i.e., to make the circular loops stretched (each loop circle isstretched longer); it is helpful for the purposes of this detaileddescription of the invention to consider each loop as a unit cell.Depending on a link from each end of the unit cell, determines howtightly each unit cell is positioned. Each entry into theskin/tissue/organ is more distantly spaced apart.

FIGS. 8C, 9C show a perspective views for one of the suture needleconfigurations, although it is not preferred, since there are too manycoils, which makes more friction for the suture inside. It would bepreferred to place the suture outside that needle when it is used.

FIGS. 8A, 9A show another compact view of a suture needle embodiment ofthe present invention; however, it is likewise not the preferredembodiment, because when the suture needle starts to rotate, there isstill a need to squeeze the wound to press together the wound edges tobe stitched. Position of hook would be straight for A, which isacceptable, but not preferred.

FIGS. 8B, 9B are preferred suture needle types (solid more preferredthan hollow) and illustrate a hybrid between the A and C configurations,where part of the spiral shape is helical; Thus, the needle is notcompletely conical; it instead progresses from spiral to helical, and isthe preferred needle embodiment—the helical-spiral (or helico-spiral)hybrid suture needle. A conic spiral (not shown) is another possibleconfiguration for the suture needle.

A compact device embodiment is preferred, wherein the last circle of thesuture needle component is spiral, with two helical and last one onbottom is spiraled out wider; the latch needle is positioned to beoperable in a vertical up and down movement. In methods preferred andillustrated in this figure, steps are included to catch the loop fromboth sides so that a catch makes a loop of the suture on both sides; onone cycle there is a catching mechanism to catch from left side; then astep to pull the latch mechanism up; then a step to retract the spiralneedle; then the catcher and the latch needle (hook) work together tocatch the loop on the other side, so it goes through first loop andpulls through the second loop, and each time comes from one side of thewound. One time it is at an acute angle; one time straight.

By way of preferred embodiment for an example or prototype of thepresent invention, a solid suture needle is provided with helical-spiralshape. While a hollow suture needle is possible, at the time of theinvention example, it is practically easier to make a device accordingto the present invention with a solid suture needle. One reason is thatit is easier to pull out the suture to make the wound tighter; anotheris that it is also easier to use a solid suture needle in combinationwith a spring-based or lever-based tensioner or tension-providingmechanism. A commercial reason for preferring a solid suture needleinstead of a hollow suture needle configuration is that the hollowsuture needle is more expensive to produce. Also, there is somedifficulty threading it, and in operation, there is additional frictionand tension in the suture needle since the suture thread passes throughand contacts the needle's internal surfaces in this hollow suture needleconfiguration. For these reasons, in the preferred embodiments at thetime of the present invention, non-hollow suture needle components areused in prototype experimentation.

Note that in FIG. 3 and the various FIGS. 3A-3J, all illustrations showthe continuous suture stitch beginning with a knot. Now regarding theillustrations of FIG. 3 and FIGS. 3A-3J, starting from position zero inthe formation of a single suture stitch unit cycle the steps are asfollows:

Position zero. The hook is positioned up; the catcher has a multiplicityof positions, preferably with 3 positions: home, catch, and pushpositions that are illustrated in the various figures. The catcher hooksthe loop when the catcher is positioned in a second position, and it isalso hooked on the loop at that time. Two alternatives are considered inprototype versions of the embodiments of the present invention that usea vertical latch needle: 1) go through the loop exactly; and/or 2) gothrough the loop & past it. If the first alternative is used, then themethods for making sutures according to and with the device and machineaccording to the present invention provide for the following steps:pushing the suture to that position to make a space for the hook to goexactly through the loop. In this step, it is very important for safetythat there be adequate space for the hook to move exactly through theloop, otherwise it is possible to lose at least one stitch in the nextor following step(s).

The suture goes through the hole in the helical spiral hybrid sutureneedle and through the tube (in the case of a hollow suture needleembodiment) up to the spool. In a prototype version according to oneembodiment of the present invention, the suture goes through the sutureneedle and through the body on the right side for pulling the suturewith an additional mechanism. Again, for commercial application, thesolid or non-hollow suture needle is preferred over use of applicationof hollow suture needle configuration since the hollow suture needle isexpensive to produce, there is some difficulty threading it, and thereis additional friction and tension in the suture needle during its usein methods of the present invention, since the suture thread passesthrough and contacts the needle's internal surfaces in this hollowsuture needle configuration. Also, a hollow needle may “core” thetissue, creating even more friction inside the needle. For thesereasons, in the preferred embodiments at the time of the presentinvention, non-hollow suture needle components are used in prototypeexperimentation.

Again, referring to the method steps illustrated in FIG. 3 and FIGS.3A-3J. Once the final position zero is returned to, a single unit cellor unit cycle is completed.

Position 1. For the next bite or next step in forming a continuoussuture stitch chain as illustrate in the Figures: shift the entiremechanism forward. The way the mechanism shifts and how the suture goesfrom the helico-spiral suture needle and pulls the loop held by thehook. If additional tension or pull is provided on the loop, it makesthe wound tighter.

Position 2. First bite or suture needle entry into the wound. Hole insuture needle near tip or sharp end to show how the suture thread orsuture material exits the suture needle and goes to tensioning device.

Position 3. Rotation is 45 degrees from p1 to p2. This is now 360degrees rotation. Radius of suture needle is smaller than the firstrotation from the tip of the suture needle b/c spiral.

One suture all the way up; 2d goes through the wound.

The figures also show stitched loops with reference to left side ofwound; right side of wound.

Next the final position of the helico-spiral suture needle beforecatching the suture is shown.

Catcher pushes the loop from the hook. The vertical needle hook islower; catcher pushes the loop & holds it in a position. At that pointthe hook starts moving down exactly through the loop because it's heldin 2 directions horizontal and vertical to assure that one loop goesthrough another; this is critical in the methods of the presentinvention.

After that hook goes through the lower position, close to thehelico-spiral suture needle to ensure that the hook passes through thespace between the suture and the helico-spiral suture needle to be readyto catch the loop.

At the bite, it is from the front side of the loop. When the sutureneedle rotates, diagram 3D, the suture needle is positioned below theloop. The helico-spiral suture needle rotates backwards 45 degrees andthe hook captures the next suture, and then pulls out the next loop. Theprior loop is inside of the helico-spiral suture needle.

The new loop is pulled through the prior loop. Next the hook ispositioned up; pusher retracts. Before retracting catcher to right, thehook is pulled up. Then retract the catcher. The chain is now madeforming the circular portion for the continuous suture stitch. Next thecatcher moves or is pushed to catch the next loop (the new loop).

Then go to or return to position zero (0).

The method steps are focused on one bite at a time for these steps inthe exploded partial views of the FIGS. 3, 3A-3J.

FIGS. 13A-13K are perspective view diagrams of the complete head portionin various positions of operation for a single cycle completing a stitchin suturing automated by the machine of the present invention. This viewdisplays the complete components of the head portion, and the drawingsin order will provide an embodiment of the device's functional processand features. The suture machine is generally referenced 10, andincludes at least the following components constructed and configured inoperable connection for automatically producing a stitch: a suturethread supply (not shown) having a first end and a second end, removably(movable) mounted on the support base via a connecting cylindrical post(not shown), a substantially spiral-shaped hollow suture needle 18movable rotationally between a first (home position) and second positionfor forming a stitch, a holding arm 36 for pushing the suture 43, and ahook 20 movable between a retracted 22 (FIGS. 13A, 13B, 13F-13K) and anextended position 23 (FIGS. 13C-13E) by an automated gear device (notshown). The suture needle 18 is connected to a suture needle shaft 17.The holding arm 36 revolves around a spindle 35 and is attached to andmoved by the holding arm rotary shaft 37 and rotary shaft wheel 38. Thehook is connected to a spring 19 that is connected to and completelysurrounds the hook rod 21.

Referring to the method steps illustrated in FIGS. 13, 13A-13K. The homeposition for the major components: suture needle 18, hook 20, andholding arm 36 (FIG. 13A). The suture needle shaft 17 takes a bite byrotating down and in helical direction of suture needle 465 degreesforming a circular loop (FIG. 13B). The hook 20 moves to extendedposition 23, moving through and past the loop of the previous stitchheld by the holding arm 36 and below the plane of the suture needle 18(FIG. 13C). The suture needle 18 rotates backward 30 degrees againsthelical direction to an intermediate position to form a loop suture (notshown) for current cycle (FIG. 13D). The hook 20 is locked picking uploop of current cycle (FIG. 13E). The hook 20 moves to intermediateretracted position holding suture thread loop out of plane of sutureneedle 18 (FIG. 13F). The holding arm or pusher 36 grabs suture threadand is rotated to push loop of previous stitch away from hook 20 and tohold loop in this position (FIG. 13G). The hook 20 moves to fullyretracted position pulling suture thread 43 exactly through extendedchain loop of previous stitch and tightening loop (FIG. 13H). The sutureneedle 18 rotates back to home position; the holding arm 36 releasesloop of previous stitch to close current circular stitch (FIG. 13I). Thehook 20 moves to home position and suture machine is forwardlyrepositioned to meet desired suture chain configurations (FIG. 13J). Theholding arm or pusher 36 returns to home position pulling previous chainloop aside in preparation for next cycle (FIG. 13K).

FIGS. 14A-14K is a perspective view diagram from an inferior angle ofthe head portion of operation for a single cycle completing a stitch insuturing automated by the machine of the present invention. This viewdisplays a focus of the head portion, and the drawings in order willprovide an embodiment of the device's functional process and features.The head portion is generally referenced 11, and includes at least thefollowing components constructed and configured in operable connectionfor automatically producing a stitch: a suture thread supply 41, threadguide 42, hook 20, suture needle 18, and holding arm 36.

Referring to the method steps illustrated in FIGS. 14, 14A-14K. Thecomponent position in these figures corresponds to the componentposition of FIGS. 13A-13K. The home positions for the majorcomponents—suture needle 18, hook 20, and holding arm 36—and the sutureneedle eyelet 16 are shown (FIG. 14A). The suture needle shaft 17 takesa bite by rotating down and in helical direction of suture needle 465degrees forming a circular loop; the helical axis of suture needle 15and circular plane of suture needle 14 are displayed (FIG. 14B). Thehook 20 moves to extended position 23, moving through and past the loopof the previous stitch held by the holding arm 36 and below the plane ofthe suture needle 18; the hook point 25, hook bend 27, and hook gape (orgap) 26 are displayed (FIG. 14C). The suture needle 18 rotates backward30 degrees against helical direction to an intermediate position to forma loop suture (not shown) for current cycle; the hook shank 24 isdisplayed (FIG. 14D). The hook 20 is locked picking up loop of currentcycle (FIG. 14E). The hook 20 moves to intermediate retracted positionholding suture thread loop out of plane of suture needle 18 (FIG. 14F).The holding arm or pusher 36 grabs suture thread and is rotated forwardpushing loop of previous stitch away from hook 20 and holding loop inposition (FIG. 14G). The hook 20 moves to fully retracted positionpulling suture thread exactly through extended chain loop of previousstitch and tightening the loop; the holding arm head 49 and holding armshaft 39 are displayed (FIG. 14H). The suture needle 18 rotates back tohome position, and the holding arm 36 releases loop of previous stitchto close current circular stitch; the holding arm head length 33 isshown (FIG. 14I). The hook 20 moves to home position and suture machineis forwardly repositioned to meet desired suture chain configurations(FIG. 14J). The holding arm or pusher 36 returns to home positionpulling previous chain loop aside in preparation for next cycle (FIG.14K).

FIGS. 15A-15T are multiple perspective view diagrams from of thecomplete head portion of the suture machine. The head portion includesat least the following components: a cylindrical post for thread supply40, thread guide 42, hook rod 21, suture needle shaft 17, holding armrotary shaft 37, rotary shaft wheel 38, hook 20, suture needle 18, andholding arm 36.

Referring to the perspective views in FIGS. 15, 15A-15T, FIG. 15A showsa left sagittal perspective view of complete head portion in homeposition, including hook rod 21, suture needle shaft 17, holding armrotary shaft 37, rotary shaft wheel 38, hook 20, suture needle 18,holding arm 36, and cylindrical post for thread supply 40. FIG. 15Bshows a left sagittal perspective view of complete head portion in homeposition without cylindrical post for thread supply. FIG. 15C shows aright sagittal perspective view of complete head portion in homeposition without cylindrical post for thread supply 40; the thread guide42 is shown. FIG. 15D shows a right sagittal perspective view ofcomplete head portion in home position with cylindrical post for threadsupply 40 and thread guide 42. FIG. 15E shows an anterior perspectiveview of complete head portion in home position. FIG. 15F shows aposterior perspective view of complete head portion in home position.FIG. 15G shows an inferior perspective view of complete head portion inhome position with edge separator 50 in foreground. FIG. 15H shows aninferior perspective view of complete head portion in home positionwithout edge separator allowing view of holding arm 36, holding armrotary shaft wheel 38, and hook 20. FIG. 15I shows a rightsagittal-anterior perspective view of complete head portion with sutureneedle 18 in first bite position rotated 465 degrees and hook 20 inextended position 23. FIG. 15J shows a right sagittal-anteriorperspective view of complete head portion with suture needle 18 rotatedbackward 30 degrees and hook 20 retracted to lock position to catchthread loop (not shown). FIG. 15K shows a left sagittal perspective viewof complete head portion with suture needle 18 in first bite positionrotated 465 degrees, hook 20 in extended position 23, and cylindricalpost for thread supply 40. FIG. 15L shows a left sagittal perspectiveview of complete head portion without cylindrical post for thread supply40 and with suture needle 18 in first bite position rotated 465 degreesand hook 20 in extended position 23. FIG. 15M shows a right sagittalperspective view of complete head portion with suture needle 18 in firstbite position rotated 465 degrees and hook 20 in extended position 23.FIG. 15N shows a posterior perspective view of complete head portionwith suture needle 18 in first bite position rotated 465 degrees andhook 20 in extended position 23. FIG. 15O shows an anterior perspectiveview of complete head portion with suture needle 18 in first biteposition rotated 465 degrees and hook 20 in extended position 23. FIG.15P shows a inferior perspective view of complete head portion withsuture needle 18 in first bite position rotated 465 degrees, hook (notshown) in extended position (not shown), and holding arm 36 in homeposition. FIG. 15Q shows a inferior perspective view of complete headportion with suture needle 18 in first bite position rotated 465degrees, hook 20 in extended position 23, and holding arm (not shown) inhome position. FIG. 15R shows a right sagittal-anterior-inferiorperspective view with focus on major components of head portion; thesuture needle 18 is in first bite position with hook 20 extended. FIG.15S shows a right sagittal-anterior-inferior perspective view with focuson major components of head portion with edge separator 50 removed toprovide complete view of extended hook 20. FIG. 15T shows a rightsagittal-anterior-inferior perspective view with expanded focus on majorcomponents of head portion to include holding arm rotating shaft wheel38; the suture needle 18 is rotated back 30 degrees, and hook 20 is inlocked position to catch loop.

FIGS. 16A, 16B refer to a preferred embodiment of the complete suturingmodule assembly 60 encased within a general housing 12. FIG. 16A is aright sagittal-anterior-superior perspective view of complete suturemachine with general housing 12. FIG. 16B is a rightsagittal-anterior-inferior perspective view of complete suture machinewith general housing 12. The general housing is removably, attachablymounted to a handle (not shown), which contains the automated geardevices. The complete handle 62 and suturing module assembly 60 aredisplayed in FIG. 17. In a preferred embodiment, the handle 62 isresterilizable separately form the suture module assembly 60. The suturemodule assembly is preferably disposable.

A difference between the embodiments of FIGS. 13-16 and FIGS. 1-5 is themechanical actuating means for moving the stitch of the previous loopaway from the hook 20. FIGS. 1-5 use a catcher comprising a push and acatch arm, which move independently but function cooperatively, whereasFIGS. 13-16 use a holding arm, which is a single L-shaped elementcontrolled by the rotation of a rotary shaft and rotary shaft wheel.More specifically, the holding arm comprises a shaft and head. The headholds the loop of the previous stitch against the hook shank so the hookcan move through the loop. After the hook has moved through the loop ofthe previous stitch to grab the loop of the current stitch, the holdingarm head moves away from the hook shank toward the hook point at leastthe length of the hook gape; this movement pushes the loop of theprevious stitch away from the hook so the hook can retract to above theholding arm head without grabbing the loop of the previous stitch.Following hook retraction, the holding arm head releases the loop of theprevious stitch and returns to its home position by completing acircular path through the hook path, where the head pulls the loop ofthe current stitch to the home position next to the hook shank.

FIG. 17A refers to a complete handle 62 and suturing module assembly 60.FIG. 17B displays an open assembly with interior handle componentsconnected to suturing module assembly components, such as the holdingarm rotary shaft 37, suture needle 18, tensioner 45, edge separator 50,the holding arm 36, holding arm wheel 38, holding arm spindle 35, sutureneedle 18, suture needle shaft 17, compound needle 30, hook 20, and hookspring 19.

An alternative embodiment incorporates a suture thread supply connectedto a tensioner 45 that extends through the housing to be externallymanipulated and is displayed in FIGS. 18A-18D. FIG. 18A shows a rightsagittal perspective view of the suturing module assembly 60 includingthe tensioner 45. FIG. 18B shows a left sagittal perspective view of thesuturing module assembly 60 including the tensioner 45. FIG. 18C shows aright sagittal-anterior perspective view of the suturing module assembly60 including the tensioner 45. FIG. 19 shows the tensioner 45. Thetensioner comprises a bolt 46 and spring 47, that compress the suturebobbin 48 when tightened. The tensioner may be manipulated external tothe general housing; by turning the tensioner to increase the drag,stitches that compress the tissue edges more tightly are created.

FIG. 20 illustrates a compound needle, generally described as 30,including a hook and a closing element or tongue. FIG. 20A displays thecompound needle components: hook 20; tongue 70; spring seat 71; andspring 19. FIG. 20B displays all the components in the compound needleclosed position; the tongue is extended to close hook access. FIG. 20Cis a detailed view of the closed compound needle. FIG. 20D displays allthe components in the compound needle open position; the tongue isretracted to open hook access. FIG. 20E is a detailed view of the opencompound needle.

Note that these diagrams are all indicated as being oriented to thewound without angle. It could be vertical for skin. If muscles or otherorgans, it may be 45 degree angle. The footer may also be angled tofacilitate suturing. For example, FIG. 21A displays a suturing moduleassembly 60 with the edge separator and a 90 degree footing. FIG. 21Bdisplays the same suturing module assembly 60 with the edge separatorremoved and a 45 degree angled footing, which allows the suture needleto stitch at an angle for potentially more optimal internal suturing. Inthe skin, you take bites parallel to skin. For muscles, fascia orinternal organs it may be preferable to angle the entire the machine, orchange the angle of the base of the machine body in a way to serve thefunction of suturing the target tissue. As will be appreciated there area variety of different suture materials may be used; these may rangefrom 10/0 smallest to #2. Refer to the tables 1 and 2 for suturematerial and for suture needles used commercially. Regarding preferredsize of suture needle, it depends on tissue type. Regarding size of thedevice, overall width is preferably less than one inch, which is aboutthe size of a basic suture width. Commercial device would be preferablyabout ½ inch. Note that the most important dimension relating to thepresent invention is the diameter of the helico-spiral suture needlespiral.

In other embodiments of the machines of the present invention, themachines are preloaded with a suture thread that is knotted at its firstend so that at the first stitch, the knot catches inside the tissue tobe stitched. Overall dimensions of the machine for automated suturing,particularly for disposable machines intended for single use applicationprovide for a machine height less than about one inch. A quick connectis preferred to attach the machine housing and functional components toa handle and motor shaft. Advantageously, the methods of the presentinvention provide for better cooptation of the wound; and this reducesthe chance of infection. If used for hollow organs, intestines, it willminimize leakage. Also note that it facilitates surgical suturing andminimizes the time of suturing. Speed is very important. The methods ofthe present invention are at least about twice as fast as manualsuturing methods.

In other embodiments of the present invention, preferably a guard isprovided to maintain the tissue to be sutured in a substantiallyedge-abutting position equal on both sides of the suture needle and hookregion of the machine; also preferably a separator at the front of thestitching area is provided, such as by way of example and notlimitation, a separator comprising a vertical plunger device ormechanism.

Certain modifications and improvements will occur to those skilled inthe art upon a reading of the foregoing description. The above-mentionedand following examples are provided to serve the purpose of clarifyingthe aspects of the invention and it will be apparent to one skilled inthe art that they do not serve to limit the scope of the invention.Other example applications include devices and methods to close skin,muscles, fascia, and hollow organs like intestines, bladder, etc. Thedevice can be modified with an extended shaft such that it can be usedthrough a laparoscope in laparoscopic and robotic surgery. Note alsothat the machine may be programmed by microprocessor, program,controlled by circuit board, timing controls and set of gears and microservos to coordinate all the motions to be fully automated andprogrammable.

Also, a footing mechanism with roller can be added to the base of thedevice where it comes in contact with the sutured tissue so as toadvance the machine in synchronized motion with the helico-spiral sutureneedle. The roller mechanism can advance the device in relation to thesutured tissue at predetermined speed.

The base (footing) of the body of the machine (device) can be modifiedto allow the device to perform subcuticular skin suturing (inserting thesuture beneath the outer layer of the skin, parallel to the skinsurface). This is a standard surgical technique that is done, prior tothis art, manually by the surgeon to achieve cosmetic healing withminimal scarring. It is a tedious process and time consuming. Thisinvention makes this process speedy and consistently accurate.

To achieve the above-mentioned objectives, the footing (not shown) ofthe device that comes in contact with the skin surface is offset. Thus,the skin surfaces of the cut are offset, FIG. 4; with one side 52 higherthan the other, lower side 53. Distance 55 in FIG. 4 represents thisoffset, which is equal to pitch of the helico-spiral suture needle, thatis, the distance 51 (the distance between the coils of the helico-spiralsuture needle).

As a result of the offsetting of the foot of the device, the skinsurface is also offset with equal distance as the device-footing offset.In an example embodiment, this distance is about 2 mm, which is theaverage thickness of the outer layer of the skin below which it isdesirable to insert the subcuticular skin sutures to achieve cosmeticresult with minimal scarring. When the helico-spiral suture needlestarts its turn stitch cycle, it first enters the subcutis on the edge52 (FIG. 4) on the side of the wound that is higher, sideways tangential(parallel) with the skin surface and preferably perpendicular to thewound edge. In cases where the edge is not planar, the surgeon can makethe appropriate entry such that the stitch will bring the tissue edgesin proper apposition. The suture needle continues its rotation beyondthe 180 degrees, going lower while rotating until it exits the firstside 52 and enters the skin edge on the lower side of the wound 53 FIG.5.

The suture needle completes a 360 degree rotation, exiting the left edgeof the wound about 1 mm below the depth of the entry point, andcontinues turning about 45 degrees to allow the hook 22 FIG. 5 to pickthe suture loop up. The helico-spiral suture needle then reversesdirection 405 degrees backwards to return to its home base in the devicehousing, thus completing one stitch cycle. Thus, the helico-spiralsuture needle rotates at least about one and one-eighth turns. The wholedevice advances forward to start another stitch cycle, the skin edgesthat have been sutured come together in apposition with edge to edgeadaptation and surface to surface configuration that provides forcosmetically acceptable scarring as healing can occur without skin edgesoverlapping and the cutis is not disturbed by sutures. Thus device thusmakes subsurface appositional sutures.

To further clarify the orientation of the device in relation to thewound, we consider the front of the wound, that area of the skin thathas not been sutured yet in front of the advancing device and the backof the wound is that area of the skin that has been sutured.

The footing of the device is flat (on the same plane) on both sidesbehind the area where the slanted surface ends and meets the flatsurface 54 FIG. 5. Thus the skin surface that has already been suturedand underneath this back part of the device housing, is on the sameplane without any offsetting, hence without skin edge overlap.

Another advantage of the subcuticular suturing technique is that thesuture material is hidden underneath the skin, thus leaving no skinmarks, compared to the standard skin stapling technique or other methodsof suturing whereas the suture material is exposed outside the skin. Thesubcuticular suture material that is proposed to be used by the deviceis absorbable by the body in few weeks (see Ethicon suture table 1) thusthere is no need to remove the suture later on. An example of suchsuture material is the mono-filament suture called Monocryl 5/0 (Ethicontrademark).

Also, keeping the suture material underneath the skin does minimize thechances of wound infection and it also eliminates the pain associatedwith removing the suture 7-10 days later on (such is the case when usingthe standard method of skin suturing). The patient also feels much lesspain associated with subcuticular suturing compared with the standardexposed sutures.

Note that the present invention provides for continuous suturing;however, the device does not move at constant speed when in use; so thenpreferred methods of the present invention provide for a visualindication showing when to move the device, and/or in automated versionsfor a machine, the machine is preferably programmed to move only whenthe suture needle is out of the tissue.

By way of example and not limitation, it is considered within the scopeof the present invention that the machines, methods, and needles may beadapted for stitching non-biologic material, or for non-medicalpurposes, such as stitching leather, artificial leather, etc. Thus, thedevice of the present invention can use different types of suturingmaterials to meet different needs. Also possible use of the device indifferent industries, such as by way of example and not limitation,veterinary medicine, textiles, automotive, industrial, and othermarkets. All modifications and improvements have been deleted herein forthe sake of conciseness and readability but are properly within thescope of the present invention.

What is claimed is:
 1. An automated method for creating subcutaneousstitches, comprising: providing a suture module with a suture needlepre-threaded with a suture material knotted at a first end to secure afirst stitch; the suture module removably coupled with a handle housingand at least one motor within the housing; forming the first stitch bypositioning the suture module between two edges of a tissue to bestitched together; activating the needle, rotating the suturesubcutaneously through the tissue at least 360 degrees; exiting a firstloop of suture from the tissue; reversing the rotation of the needlesuch that the needle is free of the tissue; moving the needle to alocation for forming a second stitch; using the needle, rotating thesuture subcutaneously through the tissue at least 360 degrees; exiting asecond loop of suture from the tissue; knitting the second loop with thefirst loop; reversing the rotation of the needle such that the needle isfree of the tissue.
 2. The method of claim 1, wherein the needle isselected from the group consisting of helical, spiral and helico-spiral.3. The method of claim 1, further including the step of separating thetwo edges of the tissue.
 4. The method of claim 1, wherein the suturemodule further includes a compound needle that exits the first loop ofsuture from the tissue, exits the second loop of suture from the tissue,and knits the first and second loops.
 5. The method of claim 4, whereinthe suture module further includes a holding arm that removes and holdsthe first loop from the compound needle.
 6. A device for makingcontinuous subsurface appositional stitches, comprising: a suture moduleremovably connected with a handle unit having a handle housing enclosinga power source, at least one motor, and a power transmission mechanismoperatively coupled to activate the suture module when connected to thehandle; the suture module comprising a suture module housing enclosing asuture needle, a compound needle, a holding arm and a suture materialprethreaded in the suture needle; the suture needle, the compound needleand the holding arm held in position by the suture module housing; thehandle unit and the suture module connected to transfer power from thehandle unit to the suture module; the suture needle shape selected fromthe group consisting of helical, helico-spiral and spiral; the compoundneedle including a hook and a tongue; the suture needle, the compoundneedle and the holding arm configured in the suture module housing toknit a series of continuous subsurface appositional stitches.
 7. Thedevice of claim 6, further including a tissue separator.
 8. The deviceof claim 6, further including a suture material supply within the suturemodule.
 9. A suture module comprising: a suture module housing, a sutureneedle, a compound needle, a holding arm and a suture materialprethreaded in the suture needle; the suture needle, the compound needleand the holding arm held in position by the suture module housing; thesuture needle shape selected from the group consisting of helical,helico-spiral and spiral; the compound needle including a hook and atongue; the suture needle, the compound needle and the holding armconfigured in the suture module housing to knit a series of continuoussubsurface appositional stitches; the suture module removably connectedwith a handle unit having a handle housing enclosing a power source, atleast one motor, and a power transmission mechanism operatively coupledto activate the suture module when connected to the handle.
 10. Thesuture module of claim 9, further including a tissue separator.
 11. Thesuture module of claim 9, further including a suture material supplywithin the suture module.